Composition for a topical cream for curtailing bleeding and treating skin disorders

ABSTRACT

An improved styptic composition which effectively curtails bleeding while administering a soothing sensation on the injured area. The styptic composition is in the form of a stable lotion or cream having the following general formula: 
     (1) from about 2% to about 12% by weight of a long chain fatty acid; 
     (2) from about 0.4% to about 3.5% by weight of a wax filler; 
     (3) from about 1% to about 10% by weight of polyethylene glycol stearate; 
     (4) from about 1% to about 5% by weight of polyethylene glycol sorbitan beeswax; and, 
     (5) from about 0.5% to about 25% by weight of an acidic metallic salt, 
     (6) the balance being water. 
     Optionally, from about 1% to about 4% by weight of glycerin may be added as a humectant. 
     Any conventional antiseptic may also be added to the composition. 
     The styptic composition may be packaged in any convenient form including jars, bottles, tubes, pump applicators, aerosol canisters and can also be impregnated into pre-packaged bandages. 
     The composition has been found useful in the treatment of certain skin disorders such as I and D of cystic acne lesions, chicken pox, seborrhea, bleeding contact dermatitis, hemorrhoids, chapped lips, and the like.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of co-pending applicationSer. No. 825,853, filed Aug. 18, 1977, now U.S. Pat. No. 4,166,108,dated Aug. 28, 1979, which was in turn a continuation-in-part of thenpending application Ser. No. 764,405, filed Jan. 21, 1977, and nowabandoned.

BACKGROUND OF THE INVENTION

This invention relates to a novel styptic composition which quickly andeffectively stanches the flow of blood from a wound without causingirritation to the skin.

The use of styptic or astringent compositions is well established in theart. As originally formulated, the compositions were comprised of highlyacidic salts of such metals as iron, zinc or aluminum that were employedas a powder or shaped in the form of a stick or pencil. Typical stypticcompositions in stick form are set forth in the U.S. Pat. Nos. 459,738,497,659 and 819,901.

In use, the acidic salts effectively curtailed the bleeding in theinjured area by causing the adjacent blood vessels to constrict.Unfortunately, the acidic nature of the salts also caused a stingingsensation which often exceeded the pain caused by the original wound.The use of these styptic compositions was therefore restricted to veryminor wounds, such as those received in shaving. If the composition wasapplied to a major wound, the pain accompanying the application wouldoften send the injured person into shock. Of course, less acidiccompositions, which caused less pain, could be utilized. However, suchcompositions had a markedly reduced effectiveness in curtailingbleeding.

A second drawback of some of the highly acidic compositions is itsdeleterious effect on any clothing with which it may come into contact.According to the type of composition and fabric, the clothing could beindelibly stained or even deteriorated.

In an attempt to obviate these problems, liquid styptic compositionswere formulated. It was hoped that by combining an acidic salt with avolatile solvent, the evaporation of the solvent would offset thestinging nature of the salt. See, for example, U.S. Pat. Nos. 2,118,225and 3,343,540. While the evaporation of the solvent took some of thepain out of the application of the styptic compound, it was found thatthe amount of styptic necessary to stop the flow of blood still caused agreat deal of discomfort and hence precluded its use in major wounds.

Aerosols, emitting a liquid or a powder, were also attempted, as shownin U.S. Pat. Nos. 3,624,201, 3,863,005, 3,928,556 and British Patent No.1,254,534. Although the aerosol containers greatly simplified theapplication of the styptic composition and kept the composition sterile,the stinging problem associated with effective bleeding curtailmentpersisted.

It is also known in the art to prepare creams or lotions containingacidic metallic salts which are stable and hence do not separate into anoil phase and an aqueous phase. These creams or lotions, however, do notrelate to styptic compositions. For example, U.S. Pat. No. 2,492,085discloses an astringent composition which is in the form of a stablecream or lotion. The stated advantages of this composition are itsnon-irritating action upon the skin and non-deteriorating effect uponclothing. These advantages are explained as resulting from the use ofaluminum chlorohydrate which has a low acidity in comparison withstronger aluminum salts, such as aluminum sulfate. The non-irritatingaction of the composition is restricted to its intended use as adeodorant. While it is almost inconceivable that a deodorant compositionwould be used as a styptic composition, if such a composition wereapplied to an open wound, a great amount of pain would result.

Another antiperspirant composition is disclosed in U.S. Pat. No.3,235,458, which is directed to an emulsified cosmetic cream. Like otherdeodorants or antiperspirants, a great amount of pain would result fromthe application to an open wound, and most commercial astringents orantiperspirants are sold with an express caveat against application tobroken skin.

Creams or lotions containing the highly acidic salt aluminum sulfate areoften unstable. As shown by the large number of compositions listed bycommercial companies, it is well known that such compounds are notequivalent or readily substituted one for another. See, for example,pages 7, 9 and 44 of Atlas Surfactants and Sorbitol, published by theAtlas Powder Company and available in the Scientific Library of the U.S.Patent and Trademark Office.

It is further known to prepare cosmetic gels which contain a variety ofmetallic salts in combination with a high molecular weight of polyvinylalcohol and methyl cellulose. See, for example, U.S. Pat. No. 3,856,941.While highly acid salts are employed, the patent does not disclose theformation of a cream or lotion, nor does it suggest that the gel can beapplied to injured areas to curtail bleeding without irritation.

It is important to note that the terms "astringent" and "styptic" arenot synonymous, and further that a "non-sting styptic composition" isclearly different from a "styptic composition". As stated on pages716-719, and 768 of Remington's Pharmalogical Sciences, 15th Edition,1975, published by Mack Publishing Company of Easton, Penn., manyastringents are irritants or caustic in moderate to high concentrations.This is particularly important where the application of the compositionis to broken skin.

It therefore an object of the present invention to provide a novelstyptic composition which overcomes or substantially alleviates theproblems of the prior art.

It is another object of the present invention to provide a novel stypticcomposition which does not sting when applied to a wound.

It is another object of the present invention to provide a novel stypticcomposition which does not stain the clothing.

It is yet another object of the present invention to provide a novelstyptic composition in the form of a cream or lotion which is highlystable.

It is a further object of the present invention to provide a novelstyptic composition having the following general formula:

(1) from about 2% to about 12% by weight of a long chain fatty acid;

(2) from about 0.4% to about 3.5% by weight of a wax filler;

(3) from about 1% to about 10% by weight of polyethylene glycolstearate;

(4) from about 1% to about 5% by weight of polyethylene glycol sorbitanbeeswax; and,

(5) from about 0.5% to about 25% by weight of an acidic metallic salt,

(6) the balance being water.

It is a further object of the present invention to provide a novelstyptic composition according to the above general formula whichcontains the optional ingredients glycerin and an antiseptic.

It is a further object of the present invention to provide a pressurizedaerosol container to distribute a novel styptic composition.

It is still a further object of the present invention to provide apre-packaged bandage which is impregnated with a novel stypticcomposition.

These and other objects, as well as the scope, nature and utilization ofthe invention, will be apparent to those skilled in the art from thefollowing description and appended claims.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The novel, non-sting styptic composition of the present invention is inthe form of a stable lotion or cream. The components other than theacidic metallic salt and the consistency of the lotion or cream exert asoothing and cooling sensation on the injured area which effectivelyovercomes the stinging sensation caused by the highly acidic metallicsalt. The ability of the salt to curtail the bleeding of the wound,however, is not affected by the balance of the components in the lotionor cream. Thus, the styptic composition not only stops the flow ofblood, but it does so with an attendant soothing sensation. Of course,if applied to major wounds, a slight stinging sensation will occur. Thedegree of pain, however, is far below that caused by known stypticcompositions and can readily be tolerated without the fear of shockoccurring.

A further surprising feature of the present invention is the stabilityof the lotion or cream. In most instances, when an acidic composition isadded to an emulsion of an oleaginous material and an aqueous mixture,the emulsion rapidly breaks down into the two phases. Incontradistinction to this normal occurrence, the styptic composition ofthe present invention exists as stable emulsion which can be stored on ashelf for months without phase separation occurring.

The stable lotion or cream has the following general formula:

(1) from about 2% to about 12% by weight of a long chain fatty acid;

(2) from about 0.4% to about 3.5% by weight of a wax filler;

(3) from about 1% to about 10% by weight of polyethylene glycolstearate;

(4) from about 1% to about 5% by weight of polyethylene glycol sorbitanbeeswax; and,

(5) from about 0.5% to about 25% by weight of an acidic metallic salt,

(6) the balance being water.

A preferred styptic composition has the following general formula:

(1) from about 4% to about 11% by weight of a long chain fatty acid;

(2) from about 1% to about 3% by weight of a wax filler;

(3) from about 4% to about 7% by weight of polyethylene glycol stearate;

(4) from about 2% to about 4% by weight of polyethylene glycol sorbitanbeeswax; and

(5) from about 5% to about 20% by weight of an acidic metallic salt,

(6) the balance being water.

The above formulas are unique in that they combine the attributes of aneffective styptic composition with the desired non-sting, non-staincharacteristics not found in the prior art. These advantages arebelieved to flow from the form of the styptic composition, namely astable lotion or cream.

The long chain fatty acid, polyethylene glycol stearate and polyethyleneglycol sorbitan beeswax are employed as emulsifiers or dispersing agentswhich promote the formation of the stable lotion or cream. Polyethyleneglycol stearate, for example, is a non-ionic emulsifier and dispersingagent which consists of a water soluble polyoxyethylene derivative ofstearic acid. This compound can be purchased under the trade nameMyrj-52 manufactured by Atlas Powder Company. Polyethylene glycolsorbitan beeswax is an analogous compound, i.e, a polyoxyethylene (20)sorbitol beeswax derivative, which can be purchased under the trade nameAtlas G-1726 which is also manufactured by Atlas Powder Company. Whilethe exact mechanism is not completely understood, the polyethyleneglycol stearate and polyethylene glycol sorbitan beeswax are alsobelieved to be primarily responsible for the soothing nature of thelotion or cream.

The term "long chain fatty acid" as used herein includes thoseunsaturated or saturated fatty acids having from nine to twenty-threecarbon atoms in the molecule. The saturated fatty acids are preferredfor purposes of the present invention. The unsaturated fatty acids, e.g.oleic acid, exhibit a tendency to oxidize and thus are typicallyemployed in conjunction with a conventional anti-oxidant. Exemplary ofsuch anti-oxidants are butylated hydroxyanisole, butylatedhydroxytoluene and propyl gallate. While the specific amount ofanti-oxidant which is added to the composition containing an unsaturatedfatty acid will depend on the particular anti-oxidant utilized, about0.02% based on the weight of the long chain unsaturated fatty acid hasgenerally been found to yield acceptable results. Exemplary of saturatedfatty acids are lauric, palmitic and, preferably, stearic acid. As maybe seen from the above general formula, the amount of fatty acidincorporated into the composition may vary from about 2% to about 12% ofthe total weight of the composition. When a fatty acid having a longercarbon chain is employed, a lesser amount is required which approachesthe lower limit of the range as the length of the carbon chainapproaches twenty-three carbon atoms. Conversely, if a fatty acid havinga shorter carbon chain is employed, a greater amount is required. Theprecise amount of a specific fatty acid in the composition can readilybe determined by routine experimentation by those of ordinary skill inthe art.

The term "wax filler" defines various wax products which increase theviscosity or consistency of the lotion or cream. Typical of such waxproducts are microcrystalline wax, paraffin wax and, preferably,beeswax.

The term "acidic metallic salt" as used herein includes those metalsalts which exhibit a degree of acidity sufficient to stanch the flow ofblood yet may be formulated into a stable lotion or cream. Typical ofsuch acidic salts are the chloride, sulfate, phenolsulfonate andchlorohydrate salts of aluminum, zinc and iron, either as a simple saltor as a dibasic salt as in the case of aluminum potassium sulfate. Thepreferred salts are those having aluminum contained therein,particularly aluminum ammonium sulfate, aluminum potassium sulfate and,as the most preferred acidic metallic salt, aluminum sulfate.Combinations of salts may also be employed. It will be apparent to thoseof ordinary skill in the art upon a perusal of the list of possibleacidic metallic salts that they do not all exhibit the same degree ofacidity. Accordingly, a greater amount of a less acidic metallic saltwill be required in the composition than in the case of a more acidicmetallic salt. The precise amount of acidic metallic salt must beselected such that the composition is effective in curtailing bleedingwithout causing an inordinate amount of pain when applied. Thesecriteria create a variation in the time needed to completely stop thebleeding, the most preferred acidic metallic salt, namely aluminumsulfate, being the most effective in curtailing bleeding without causingpain. In all instances, however, the amount of acidic metallic saltrequired in the composition will fall within the limits established bythe above formula.

The following Examples are given as specific illustrations of theinvention. It should be understood, however, that the invention is notlimited to the specific details set forth therein. In the followingExamples, all percentages are by weight of the total composition.

EXAMPLE I

    ______________________________________                                        (1)     Stearic Acid            7.5%                                          (2)     Beeswax                 1.7%                                          (3)     Polyethylene glycol stearate                                                                          5.3%                                          (4)     Polyethylene glycol sorbitan beeswax                                                                  3.5%                                          (5)     Aluminum sulfate        13%                                           (6)     Water                   69%                                           ______________________________________                                    

EXAMPLE II

    ______________________________________                                        (1)    Palmitic acid           9%                                             (2)    Microcrystalline Wax    2.5%                                           (3)    Polyethylene glycol stearate                                                                          3.8%                                           (4)    Polyethylene glycol sorbitan beeswax                                                                  2.3%                                           (5)    Aluminum Potassium Sulfate                                                                            10%                                            (6)    Water                   72.4%                                          ______________________________________                                    

EXAMPLE III

    ______________________________________                                        (1)    Lauric acid             11%                                            (2)    Paraffin Wax            3.0%                                           (3)    Polyethylene glycol stearate                                                                          6.2%                                           (4)    Polyethylene glycol sorbitan beeswax                                                                  4%                                             (5)    Zinc Sulfate            18%                                            (6)    Water                   57.8%                                          ______________________________________                                    

A humectant may optionally be present in an amount ranging from about 1%to about 4% by weight. Although the humectant does not affect theability of the styptic lotion or cream to stanch the flow of blood, itis generally incorporated into the composition to prevent the lotion orcream from drying out. Typical of the humectants which may be employedare the polyhydric aliphatic compounds. Glycerin is the preferredhumectant.

Any conventional antiseptic may also be incorporated into thecomposition. Such antiseptics include the quaternary ammonium compoundsand the alcohol compounds including phenol compounds. One preferredantiseptic composition is hexylresorcinol. The amount of antisepticutilized in the composition will depend on the particular compoundemployed. Since most known antiseptic compounds cause some degree ofstinging, the amount of antiseptic utilized should be maintained at theminimum amount necessary to effectively prevent the growth ofmicroorganisms. In the case of hexylresorcinol this amount is in theorder of about 2% by weight.

The above mentioned ingredients may be combined in the following manner:long chain fatty acid, the wax filler, polyethylene glycol stearate,polyethylene glycol sorbitan beeswax and, optionally, glycerin are mixedtogether and heated to a temperature of about 70° C. After the mixturehas reached this temperature, a warm (70° C.) aqueous solution of thehighly acidic metallic salt is blended in. The mixture is then cooledwhile being agitated.

The resulting stable cream or lotion is an effective styptic compositionwhich has a wide range of applications. In use, the cream or lotion isspread on the wound and is quickly absorbed by the skin. Therefore, ifsuturing is required or desired, it may be performed without having toclean the wound of the styptic composition. Due to its non-stingcharacteristic, the styptic composition of the present invention may bespread on minor cuts, abrasions and even major wounds without causingpain to the injured entity. The term "entity" is utilized to reflect thefact that the syptic composition of the present invention is effectiveon animals as well as humans. The composition can also be employed inthe dental field if a flavoring agent is added and can be incorporatedinto first-aid kits for civilian and military use.

A second advantageous feature of the styptic composition of thisinvention is that it does not stain or deteriorate fabrics with which itcomes in contact. This feature enables the composition to be applied toa small cut or abrasion on an area of skin which is normally covered byclothing without the need for a restrictive bandage or covering.

The cream or lotion which comprises the styptic composition of thisinvention can be packaged in any convenient container including jars,bottles, tubes, pump applicators and preferably, in pressurized aerosolcanisters. The aerosol canisters which may be employed to distribute thelotion or cream are well known in the art so that a further expositionof the details of the canisters need not be set forth here (see forexample, U.S. Pat. Nos. 2,631,814, 2,645,387 and 2,662,668, the contentsof which are incorporated by reference). In an aerosol canister, thecomposition may be maintained in a sterile condition irrespective of thesurrounding environment and may be directly applied where needed with aminimum of effort.

The styptic composition of the present invention may also be utilized toimpregnate prepackaged bandages. The wound covering area of the bandagesmay be fabricated out of natural fibers, such as cotton, man-madefibers, such as polyester or rayon or mixtures thereof. According to thetype of fabric employed, the bandage density and thickness and the typeof wound intended to be covered, it is necessary to vary the amounts ofthe several components which comprise the styptic composition. However,such variation will fall within the ranges established above. In thisform, the combination of the styptic composition and the bandage may bemaintained in a sterile package. When required, it may be quickly openedand applied to the wound thereby stanching the flow of blood, easing thepain of the wound and initiating the healing process without delay. Suchadvantages make the impregnated bandage particularly suitable for firstaid kits, emergency units, physician's bags and a variety of otherlocations.

The composition has been found to have great utility in the treatment ofcertain skin disorders, such as I and D of cystic acne lesions, chickenpox, seborrhea. Other uses include application to mucosal surfaces, tochapped lips, to combat nasal dryness and to heal bleeding contactdermatitis. A further application is in the treatment of hemorrhoids. Inall such instances in which clinical experiments were conducted, thecomposition exhibited marked healing properties in a remarkably shorttime.

Although the invention has been described with reference to preferredembodiments, it is to be understood that variations and modificationsmay be employed without departing from the scope of the invention asdefined in the following claims.

What is claimed is:
 1. A non-sting styptic composition as a stable creamor lotion comprising:(1) from about 2% to about 12% by weight of a longchain fatty acid selected from the group saturated or unsaturated havingfrom nine to twenty-three carbon atoms therein; (2) from about 0.4% toabout 3.5% by weight of a wax filler; (3) from about 1% to about 10% byweight of polyethylene glycol stearate; (4) from about 1% to about 5% byweight of polyethylene glycol (20) sorbitan beeswax; and, (5) from about0.5% to about 25% by weight of an acidic metallic salt, said acidicmetallic salt being characterized by possessing a degree of aciditysufficient to stanch the flow of blood and being capable of beingformulated into said stable cream or lotion, (6) the balance beingwater.
 2. The styptic composition of claim 1, wherein the acidicmetallic salt is selected from the group consisting of aluminum sulfate,aluminum potassium sulfate and aluminum ammonium sulfate.
 3. The stypticcomposition of claim 2, wherein the acidic metallic salt is aluminumsulfate.
 4. The styptic composition of claim 3, wherein the wax filleris beeswax.
 5. The styptic composition of claim 4, wherein the longchain fatty acid is stearic acid.
 6. The styptic composition of claim 1,wherein the wax filler is selected from the group consisting of beeswax,microcrystalline wax and paraffin wax.
 7. The styptic composition ofclaim 1, wherein a humectant is present in an amount ranging from about1% to about 4% by weight.
 8. The styptic composition of claim 7, whereinthe humectant is glycerin.
 9. The styptic composition of claim 7including an antiseptic.
 10. A non-sting styptic composition as a stablecream or lotion as set out in claim 1 wherein the wax filler is selectedfrom the group consisting of microcrystalline wax, paraffin wax andbeeswax; andwherein the acidic metal salt is selected from the groupconsisting of aluminum phenolsulfonate, zinc phenolsulfonate, and ferricphenolsulfonate.
 11. The composition of claim 1 wherein the acidic metalsalt is selected from the group consisting of aluminum phenolsulfonate,zinc phenolsulfonate, and ferric phenolsulfonate.
 12. The composition ofclaim 11, wherein the wax filler is beeswax.
 13. The composition ofclaim 11, wherein a humectant is present in an amount ranging from about1% to about 4% by weight.
 14. The composition of claim 13, wherein thehumectant is glycerin.
 15. An improved styptic composition which doesnot sting or stain clothes when applied, and composition being in theform of a stable cream or lotion which includes:(1) from about 2% toabout 12% by weight of a long chain fatty acid; (2) from about 0.4% toabout 3.5% by weight of a wax filler; (3) from about 1% to about 10% byweight of polyethylene glycol stearate; (4) from about 1% to about 5% byweight of polyethylene glycol sorbitan beeswax; and, (5) from about 0.5%to about 25% by weight of an acidic metallic salt, (6) the balance beingwater.
 16. A pressurized aerosol canister containing an improvednon-sting, non-stain styptic composition, said styptic composition beingin the form of a stable lotion or cream which includes:(1) from about 2%to about 12% by weight of a long chain fatty acid; (2) from about 0.4%to about 3.5% by weight of a wax filler; (3) from about 1% to about 10%by weight of polyethylene glycol stearate; (4) from about 1% to about 5%by weight of polyethylene glycol sorbitan beeswax; and, (5) from about0.5% to about 25% by weight of an acidic metallic salt, (6) the balancebeing water.
 17. The pressurized aerosol canister of claim 16, whereinthe acidic metallic salt is selected from the group consisting ofaluminum sulfate, aluminum potassium sulfate and aluminum ammoniumsulfate.
 18. The pressurized aerosol canister of claim 17, wherein theacidic metallic salt is aluminum sulfate.
 19. The pressurized aerosolcanister of claim 18, wherein the wax filler is beeswax.
 20. Thepressurized aerosol canister of claim 16, wherein the wax filler isselected from the group consisting of beeswax, microcrystalline wax andparaffin wax.
 21. The pressurized aerosol canister of claim 16, whereinglycerin is present in an amount ranging from about 1% to about 4% byweight.
 22. A bandage having a wound covering area composed of fibersselected from the group consisting of natural fibers, man-made fibersand mixtures thereof, said bandage including a non-sting, non-stainstyptic composition, said styptic composition being in the form of astable cream or lotion which includes:(1) from about 2% to about 12% byweight of a long chain fatty acid; (2) from about 0.4% to about 3.5% byweight of a wax filler; (3) from about 1% to about 10% by weight ofpolyethylene glycol stearate; (4) from about 1% to about 5% by weight ofpolyethylene glycol sorbitan beeswax; and, (5) from about 0.5% to about25% by weight of an acidic metallic salt, (6) the balance being water.23. The bandage of claim 22, wherein the acidic metallic salt isselected from the group consisting of aluminum sulfate, aluminumpotassium sulfate and aluminum ammonium sulfate.
 24. The bandage ofclaim 23, wherein the acidic metallic salt is aluminum sulfate.
 25. Thebandage of claim 23, wherein the wax filler is beeswax.
 26. The bandageof claim 22, wherein the wax filler is selected from the groupconsisting of beeswax, microcrystalline wax and paraffin wax.
 27. Thebandage of claim 22, wherein a humectant is present in an amount rangingfrom about 1% to about 4% by weight.
 28. A non-sting styptic compositionas a stable cream or lotion comprising:(1) from about 2% to about 12%weight of a saturated or unsaturated long chain fatty acid having fromnine to twenty-three carbon atoms therein and selected from the groupconsisting of oleic acid, lauric adic, palmitic acid and stearic acid;(2) from about 0.4% to about 3.5% by weight of a wax filler selectedfrom the group consisting of microcrystalline wax, paraffin wax andbeeswax; (3) from about 1% to about 10% by weight of polyethylene glycolstearate; (4) from about 1% to about 5% by weight of polyethylene glycol(20) sorbitan beeswax; and, (5) from about 0.5% to about 25% by weightof an acidic metallic salt selected from the group consisting ofaluminum phenolsulfonate, zinc phenolsulfonate, and ferricphenolsulfonate, said acidic metallic salt being characterized bypossessing a degree of acidity sufficient to stanch the flow of bloodand being capable of being formulated into said stable cream or lotion,(6) the balance being water.